Monoject

Enteral Syringe with Tip Cap

Registry build 21.09.26
68manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (14), Zhejiang (13), Shanghai (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KYW
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Biomed Plastics Co. Taicang Jiangsu Contract manufacturer 29
Hangzhou Dunli Medical Instruments Co., Ltd. Hangzhou Zhejiang Contract manufacturer 16
Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. Longgang Dist, Shenzhen Guangdong Contract manufacturer 15
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Foshan Guangdong Contract manufacturer 11
JIE GAO Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Shantou Wealy Medical Instrument Co., Ltd. Shantou Guangdong Contract manufacturer 10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Yangzhou Yichuan Plastic Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 8

Showing 12 of 68. All 68 manufacturers in China registered for Container, Liquid Medication, Graduated

Record

Regulatory record for Monoject
Listed by Cardinal Health, United States
FDA product code KYW
Device type Container, Liquid Medication, Graduated
Device class Class 1
Regulation 21 CFR 880.6430
Establishment Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-06-30
Record revised 2023-07-03 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT
Packaging Case of 500, pack_or_inner_pack of 100, case of 400, pack_or_inner_pack of 120, case of 480, pack_or_inner_pack of 40
Sizes Total volume 1 to 60 ml
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for Monoject
Catalogue number Size Per pack Status
8881907003 Total Volume 10 ml 100 In distribution
8881907102 Total Volume 10 ml 100 In distribution
8881903002 Total Volume 3 ml 100 Withdrawn
8881901006 Total Volume 1 ml 100 Withdrawn
8881907199 Total Volume 10 ml 480 Withdrawn
8881901014 Total Volume 1 ml 100 Withdrawn
406SG Total Volume 6 ml Withdrawn
8881682585 23,000 Withdrawn
403SG Total Volume 3 ml Withdrawn
435SG Total Volume 35 ml Withdrawn
412SG Total Volume 12 ml Withdrawn
460SG Total Volume 60 ml Withdrawn
8881906104 Total Volume 6 ml 100 Withdrawn
8881906005 Total Volume 6 ml 100 Withdrawn
8881903010 Total Volume 3 ml 100 Withdrawn
401SG Total Volume 1 ml Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Health Care Logistics, Inc® Health Care Logistics, Inc. 57
Bioseal Inc. Bioseal 17
CHS Canadian Hospital Specialties Ltd. 15
Marina Medical Marina Medical Instruments, Inc. 13
Monoject Cardinal Health 200, LLC 13
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 12
Medegen Medical Products, LLC Medegen Medical Products 11
BD Oral Syringe Becton, Dickinson AND Company 8
V. Mueller Steris Corporation 8
Alleset GRI Medical & Electronic Technology Co., Ltd. 8
Cardinal Health Cardinal Health 200, LLC 8
MSI Precision Specialty Instruments MED Saver, Inc. 6

Showing 12 of 60. All products under Container, Liquid Medication, Graduated

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer